Coded cartridge assembly

ABSTRACT

Disclosed herein are cartridge assemblies that include coding features that help dedicate a medicament reservoir to specific injection devices. An exemplary cartridge assembly comprises a cylindrical inner surface for holding medicament and a cylindrical outer surface comprising at its proximal end one or more stops configured as coding elements protruding from the cylindrical outer surface. Each coding element is configured only to engage a corresponding coding feature on a dose setting and delivery mechanism, thereby allowing only the correct cartridge assembly to connect to the dose setting and delivery mechanism.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is continuation of U.S. patent application Ser.No. 13/642,077, filed Dec. 21, 2012, which is a U.S. National PhaseApplication pursuant to 35 U.S.C. §371 of International Application No.PCT/EP2011/056482 filed Apr. 21, 2011, which claims priority to U.S.Provisional Patent Application No. 61/327,284 filed Apr. 23, 2010 andEuropean Patent Application No. 10171170.3 filed Jul. 29, 2010. Theentire disclosure contents of these applications are herewithincorporated by reference into the present application.

FIELD OF INVENTION

The present patent application is generally directed to medical deliverydevices that comprise a cartridge assembly and a dose setting member, inparticular to cartridge assemblies that have coding features, e.g. stopfeatures, that engage complimentary coding features, e.g. counter stopfeatures, on the dose setting member to ensure the appropriate cartridgeassembly is connected to the appropriate dose setting member.

BACKGROUND

Medicament reservoirs such as ampoules, cartridges, or vials aregenerally known. Such reservoirs are especially used for medicamentsthat may be self administered by a patient. For example, with respect toinsulin, a patient suffering from diabetes may require a certain amountof insulin to either be injected via a pen type injection syringe orinfused via a pump. With respect to certain known reusable pen type drugdelivery devices, a patient loads a cartridge containing the insulininto a cartridge holder. The cartridge plus the holder is one type ofcartridge assembly. After the cartridge has been correctly loaded, theuser may then be called upon to select a dose of medicament. Multipledoses may be dosed from the cartridge. Once the cartridge is empty, thecartridge must be removed and replaced with a new cartridge. Mostsuppliers of such cartridges recommend that the user dispose of theempty cartridges properly.

Such known self-administration systems requiring the removal andreloading of empty cartridges have certain limitations. For example, incertain generally known systems, a user simply loads a new cartridgeinto the delivery system without the drug delivery device or without thecartridge having any mechanism of preventing cross use of an incorrectcartridge. That is, the drug delivery device does not have a mechanismfor determining if the medicament contained in the cartridge is indeedthe correct type of medicament to be administered by the patient.Alternatively, the drug delivery device does not present a mechanism fordetermining if the correct type of medicament within the cartridgeshould be used with that particular drug delivery system. This potentialproblem could be exacerbated given that certain elderly patients, suchas those suffering from diabetes, may have limited manual dexterity.Identifying an incorrect medicament is quite important, since theadministration of a potentially incorrect dose of a medicament such as ashort acting insulin in lieu of a long insulin could result in injury oreven death.

Some drug delivery devices or systems may use a color coding scheme toassist a user or care giver in selecting the correct cartridge to beused with a correct drug delivery device. However, such color codingschemes pose challenges to certain users, especially those userssuffering from poor eyesight or color blindness: a situation that can bequite prevalent in patients suffering from diabetes.

Another concern that may arise with disposable replaceable cartridges isthat these cartridges are manufactured in essentially standard sizes andmust comply with certain recognized local and international standards.Consequently, such cartridges are typically supplied in standard sizedcartridges (e.g., 3 ml cartridges). Therefore, there may be a variety ofcartridges supplied by a number of different suppliers and containingdifferent medicament but that may fit a single drug delivery device. Asjust one example, a first cartridge containing a first medicament from afirst supplier may fit a medical delivery device provided by a secondsupplier. As such, a user might be able to load and then dispense anincorrect medicament (such as a rapid or basal type of insulin) into adrug delivery device without being aware that the medical deliverydevice was perhaps not designed or intended for use with such acartridge and therefore the medicament contained within that cartridge.

As such, there is a growing desire from users, health care providers,care givers, regulatory entities, and medical device suppliers to reducethe potential risk of a user loading an incorrect drug type into a drugdelivery device. There is also, therefore, a desire to reduce the riskof dispensing an incorrect medicament (or the wrong concentration of themedicament) from such a drug delivery device.

There is, therefore, a general need to physically dedicate ormechanically code the fastening features that allow cartridgeassemblies, whether it is a cartridge holder or a molded cartridgewithout a separate holder, to be attached to dose setting portion of aninjection device. In this way a particular drug type or types are linkedto the appropriate injection device (e.g., dose setting member).Similarly, there is also a general need for a dedicated cartridge thatallows the medical delivery device to be used with only an authorizedcartridge containing a specific medicament and preventing undesiredcartridge cross-use. There is also a general need to provide a dedicatedfastening feature on the cartridge assembly that is difficult to tamperwith so that the cartridge assembly may not be compromised in that themedicament can be used with an unauthorized drug or drug deliverydevice. Because such cartridge assemblies may be difficult to tamperwith, they may also reduce the risk of counterfeiting: i.e., making itmore difficult for counterfeiters to provide unregulated counterfeitproducts.

It is an aim to provide an improved coded cartridge assembly to beattached to a dose setting member of an injection device.

SUMMARY

This aim may be achieved by a cartridge assembly which is configured tobe connected to a dose setting and delivery mechanism, the cartridgeassembly comprising a cylindrical body for holding a medicamentreservoir, where the cylindrical body has a proximal end having an outersurface and an inner surface. A fastener is provided on either the outersurface or the inner surface of the proximal end portion, the fastenerbeing suitable for attaching the cartridge assembly to dose setting anddelivery mechanism. The cartridge assembly further comprises at leastone coding feature that is separate from the fastener. In one embodimentthe coding feature is coded to engage a corresponding coding feature onthe dose setting and delivery mechanism, thereby allowing the cartridgeassembly to operably connect to the dose setting and delivery mechanism.The coding feature ensures that the cartridge assembly can be attachedto the corresponding dose setting and delivery mechanism so that thedevice is operable. If a user tries to attach the cartridge assembly toanother dose setting device, the code features would block attachment.

Disclosed herein are cartridge assemblies that include coding featuresthat help dedicate a medicament reservoir to specific injection devices.An exemplary cartridge assembly comprises a cylindrical inner surfacefor holding medicament and a cylindrical outer surface comprising at itsproximal end one or more stops configured as coding elements protrudingfrom the cylindrical outer surface. Each coding element is configuredonly to engage a corresponding coding feature on a dose setting anddelivery mechanism, thereby allowing only the correct cartridge assemblyto connect to the dose setting and delivery mechanism.

A injection device may be a drug delivery device designed to dispense aselected dose of a drug, e.g. insulin, insulin analogues, growthhormones, heparins and their derivates etc., optionally suitable forself-administration. The dose may be fixed or variable. The device maybe of mechanical type or may comprise electronic elements. The devicemay be a mobile, hand-held device, e.g. a drug delivery pen type device.The device may be disposable or reusable. The device comprises a dosesetting and delivery mechanism, in short dose setting member, whichenables to set and deliver a dose.

A cartridge assembly may be formed as a cartridge holder suitable forcontaining a cartridge or as a molded cartridge without separate holder.The fastener is suitable to connect the cartridge assembly to the dosesetting and delivery mechanism. The fastener may be selected from thegroup consisting of threads, pins and grooves, pins and ridges, bayonet,snap-fit, and detents. A cylindrical body may be a tubular body whichmay have an essentially circular cross section. The form of the crosssection is not limited to a circle.

The coding features may be located on either the outer surface, theinner surface, or an axial end of the cylindrical body. The codingfeature may be any indentation or protrusion, in any direction, of anysize, and/or of any shape, from a cartridge holder or dose settingmember. The coding feature and the corresponding coding feature match sothat the cartridge assembly can be operably connected to the dosesetting and delivery mechanism, when the coding feature and thecorresponding coding feature engage which may mean interlocking of thecoding feature and the corresponding coding feature. In other words, ifthe dose setting and delivery mechanism does not comprise correspondingcoding features, the cartridge assembly cannot be attached to the dosesetting and delivery mechanism so that they accurately fit together andso that the injection device works. The coding feature may be formed asstop feature and the corresponding coding feature may be formed ascounter stop feature. The stop feature and the counter stop feature aresuitable to interlock or make contact thereby blocking travel in theconnection process and allowing the cartridge assembly to operablyconnect to the dose setting and delivery mechanism. The movement of thecartridge assembly during attachment may be stopped when the stopfeature touches the counter stop feature. This enables to attach thecartridge assembly to the dose setting and delivery mechanism so thatthe injection device is operable. The stop feature may be configured tocontact the counter stop feature in an axial, helical or circumferentialdirection. In one embodiment the stop feature is configured to contactthe counter stop feature in the direction that is normal to thedirection of travel of the cartridge assembly at the time of contact.

The cartridge assembly may be coded to a dose setting member using stopfeatures that are located at the proximal end of the cartridge assemblyto ensure that a user of an injection device does not mistakenly use theincorrect medicament. In one aspect, a cartridge assembly, defined as acartridge in a holder or a molded cartridge without a separate holder,for containing a reservoir of medicament is disclosed having a fastenerat the proximal end (i.e. the end that attaches to a dose settingdevice), which includes one or more coding features matched to afastener located on the distal end of a dose setting device. Thefastener/coding features operably connect the cartridge assembly tomatched fastener/coding features on the dose setting device, thusallowing the user to administer an injection of the desired medicament.

The integral coding/fastener features can comprise combinations, suchas, a pin and ridge, a pin and a pin, a ridge and a pair of pins, a pinand groove, and a screw thread. The use of detents to lock the cartridgeassembly to the dose setting member is also advantageous. The cartridgeassembly comprises a tubular member having a cylindrical inner surfaceand a cylindrical outer surface having a fastener on either surfacecomprising a first coding feature that is coded to engage a secondcoding feature on a complimentary fastener on a dose setting member,thereby allowing the cartridge assembly to operably connect to the dosesetting member. The coding features integral with the cartridge assemblyfastener and the complementary fastener on the dose setting assembly canbe any combination of pins, ridges, ribs, grooves, slots, protrusions,valleys, and like structures provided that coding features are matchedand allow to two assemblies to be operably connected, i.e. like a key ina lock or pieces in a jigsaw puzzle.

In one possible exemplary embodiment, the cartridge assembly for holdinga medicament reservoir, the assembly comprises a cylindrical body forholding the medicament reservoir, where the cylindrical body has aproximal outer surface positioned between a shoulder and a proximalaxial end that also has a fastener on the proximal outer surface. Thereis at least one stop on the proximal outer surface that is coded toengage a corresponding coding stop feature on a dose setting member,thereby allowing the assembly to operably connect to the dose settingmember. In a preferred configuration the stop is a pin that abuts aproximal facing surface of the shoulder which may be positioned on theouter surface of the proximal end. This stop can be a radial pin or anaxial pin. Likewise, there can be a plurality of stops offset from eachother and/or different in size in the axial, circumferential or radialextent from each other. Most preferably, the stop is separate from thefastener.

In yet another configuration the stop is an indentation and thecorresponding coding stop feature located on the dose setting member isa pin.

In one embodiment the cartridge assembly is configured to be rotateduntil the pin contacts a counter stop face of a groove feature that isan axial indentation on a circular ridge of dose setting mechanism.

A medicament delivery device may comprise a dose setting member and acartridge assembly for holding a medicament reservoir, where theassembly comprises a cylindrical body for holding the medicamentreservoir, where the cylindrical body has a proximal outer surfacepositioned between a shoulder and a proximal axial end. There is afastener on the proximal outer surface having a connecting direction andat least one stop on the proximal outer surface that is coded to engagea corresponding coding feature on the dose setting member, wherein thedose member allows the assembly to operably connect to the dose settingmember.

The corresponding coding feature on the dose setting member is a counterstop and the engagement is on a face that lies in the radial plane ofthe counter stop. Alternatively, the corresponding coding feature on thedose setting member is a counter stop and the engagement with the stopis on a face that lies in the longitudinal plane. The direction ofcontact between the corresponding stop features would preferably benormal to the fastener connecting direction. Further, the correspondingcoding feature could be an indentation configured to accept the stopwhen the dose setting member and cartridge assembly are operablyconnected.

Coding may be achieved by varying the coding features in a number ofways including, but not limited to, the following:

-   -   i. Number of features.    -   ii. Position of features—axial/circumferential/radial,        especially relative to a standard feature, e.g. axial length        from one end or from a fastening means.    -   iii. Size of features, e.g. axial/circumferential/radial extent.        The size of each feature may be different from at least one of        the others, e.g. a number of coding pins with different radial        extents.    -   iv. Cross-sectional shape of the features in any plane, e.g.        longitudinal, transverse, or normal to a helix, but preferably        in a plane normal to the fastening action.

The angle of coding faces on the cartridge assembly and thecomplimentary coding feature on the dose setting member and the way thatthey contact each other may be in any direction. For example, contactmay be in the axial/helical/circumferential directions, althoughpreferably in the direction of the fastening action. The coding featuresmay be pins or cover a significant proportion of the outside of thecartridge assembly.

If the cartridge assembly fits in only one orientation, the number ofcoding combinations is increased. This might be achieved if one or moreof the coding features (or an additional feature) has an asymmetricposition or size around the axis, or if one of the features is unique,e.g. an indentation that is smaller than all the others. Alternatively,the coding may be included more than once, offering redundancy in caseone set of coding is damaged, and also allowing the user to insert thecartridge assembly in more than one orientation.

Coding may depend on more than one coding feature. A coding system mayconsist of a number of features, one of which blocks travel earlier inthe fastening action than all other features, and one of which blockstravel later than all other features. With only one feature, a codingfeature that blocks travel early in the fastening action will fit into adevice where travel should be blocked later. By combining two features,all drugs can be prevented from fitting into the wrong devices.

In one embodiment a first and a second cartridge assembly are providedwhere the first cartridge assembly holds a first medicament and thesecond cartridge assembly holds a second medicament different from thefirst medicament. The coding feature of the first cartridge assembly isunique to the first medicament and is specifically coded to engage onlya corresponding coding feature on a dose setting and delivery mechanismthat is configured to dispense the first medicament and where the secondcartridge assembly will not operably connect to the first dose settingand delivery mechanism.

The coding feature of the second cartridge assembly may be unique to thesecond medicament and is specifically coded to engage only acorresponding coding feature on a dose setting and delivery mechanismthat is configured to dispense the second medicament.

A third cartridge assembly holding a third medicament different from thefirst and second medicaments may be provided, where the coding featureof the third cartridge assembly is unique to the third medicament andwhere the third cartridge assembly operably connects only to a thirddose setting and delivery mechanism that is different from other dosesetting and delivery mechanisms. The first and second cartridgeassemblies are a collection of cartridge device, where the codingfeatures prevents that the cartridge assemblies are attached to thewrong dose setting and delivery mechanisms.

In one embodiment the cartridge assemblies have the same type offasteners, and wherein the coding feature of the first assembly isdifferent from the coding feature of the second assembly. Thus, thehandlings of the cartridge assemblies are similar, but none of thecartridge assemblies in the system can be fitted to incorrect devices.

A collection of cartridge assemblies each having coded stop features toallow for connection of reservoirs of different medicaments to specificmatched dose setting members to make up a family of injection devices.For example, the collection can have two or more cartridge assemblies,where a first cartridge assembly comprises (a) a tubular member having acylindrical inner surface and a cylindrical outer surface at a proximalend, (b) a first medicament inside the tubular member, (c) a fastener onthe cylindrical outer or inner surface of the tubular member, and (d) acoded stop separate from the fastener located on the proximal end of thetubular member comprising a first coding feature that is unique to thefirst medicament and is specifically coded to engage only acorresponding coding stop feature on a dose setting member on a firstdose setting member that is configured to dispense the first medicament.The first coding feature is different than a second coding feature on acoded stop on a second cartridge assembly in the collection thatcontains a second medicament, where the first and second medicaments aredifferent and where the second cartridge assembly will not operablyconnect to the first dose setting member, thereby preventing the firstdosing setting member from administering the second medicament.

Additionally, the collection could further comprise a third cartridgeassembly having a coded stop comprising a third coding feature unique toa third medicament contained in the third cartridge assembly that isdifferent than the first and second medicaments and where the thirdcartridge assembly operably connects only to a third dose setting memberthat is different from other dose setting members in the family ofinjection devices. All the coded stops of the cartridge assemblies inthe collection may also have the same type of fastening feature selectedfrom the group consisting of threads, pins & grooves, pins & ridges,bayonet, snap-fit, and detents, and wherein each coding featureassociated with each coded stop is different from all the other codingfeatures on the other coded stops on the cartridge assemblies in thecollection.

In a system in which helical travel is followed by rotational travel,coding features may prevent travel into the rotational phase if the drugis incorrect. This will make it obvious to the user that the drug isincorrect. The fastening action may stop due to features within thefastening means, e.g. when the pin reaches the end of the groove.Alternatively, the coding features may provide the only stop. If thecoding features provide the stop, the cartridge assembly may over-rotateif the incorrect drug is inserted. It may then be ejected along agroove, which may have a one-way element to prevent entry into thegroove during normal fastening. Although preferred embodiments areillustrated with the fastening means as a pin on the device following agroove on the cartridge assembly, and the travel is axial then helicalthen rotational, the coding may be used with any fastening means and anycombination of directions in the travel, including purely axial travel.

Coding could block all incorrect drugs or just the most dangerous, e.g.a short-acting drug can be fitted into a device intended for long-actingdrugs, or a low concentration drug into a device for high concentration,but not vice versa. Coding features may be detected byelectro-mechanical means, e.g. microswitches, or optical/magneticswitches. A programmable pen could then respond to the drug type, e.g.by limiting the maximum dose.

These as well as other advantages of various aspects will becomeapparent to those of ordinary skill in the art by reading the followingdetailed description, with appropriate reference to the accompanyingdrawings.

The terms “drug” or “medicament”, as used herein, preferably mean apharmaceutical formulation containing at least one pharmaceuticallyactive compound,

wherein in one embodiment the pharmaceutically active compound has amolecular weight up to 1500 Da and/or is a peptide, a proteine, apolysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody, ahormone or an oligonucleotide, or a mixture of the above-mentionedpharmaceutically active compound,

wherein in a further embodiment the pharmaceutically active compound isuseful for the treatment and/or prophylaxis of diabetes mellitus orcomplications associated with diabetes mellitus such as diabeticretinopathy, thromboembolism disorders such as deep vein or pulmonarythromboembolism, acute coronary syndrome (ACS), angina, myocardialinfarction, cancer, macular degeneration, inflammation, hay fever,atherosclerosis and/or rheumatoid arthritis,

wherein in a further embodiment the pharmaceutically active compoundcomprises at least one peptide for the treatment and/or prophylaxis ofdiabetes mellitus or complications associated with diabetes mellitussuch as diabetic retinopathy,

wherein in a further embodiment the pharmaceutically active compoundcomprises at least one human insulin or a human insulin analogue orderivative, glucagon-like peptide (GLP-1) or an analogue or derivativethereof, or exedin-3 or exedin-4 or an analogue or derivative ofexedin-3 or exedin-4.

Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) humaninsulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) humaninsulin; Asp(B28) human insulin; human insulin, wherein proline inposition B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein inposition B29 Lys may be replaced by Pro; Ala(B26) human insulin;Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) humaninsulin.

Insulin derivates are for example B29-N-myristoyl-des(B30) humaninsulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl humaninsulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N—(N-palmitoyl-Y-glutamyl)-des(B30) human insulin;B29-N—(N-lithocholyl-Y-glutamyl)-des(B30) human insulin;B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(ω-carboxyheptadecanoyl) human insulin.

Exendin-4 for example means Exendin-4(1-39), a peptide of the sequenceH-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives are for example selected from the following listof compounds:

H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2, H-(Lys)5-des Pro36,des Pro37 Exendin-4(1-39)-NH2, des Pro36 [Asp28] Exendin-4(1-39), desPro36 [IsoAsp28] Exendin-4(1-39), des Pro36 [Met(O)14, Asp28]Exendin-4(1-39), des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39), desPro36 [Trp(O2)25, Asp28] Exendin-4(1-39), des Pro36 [Trp(O2)25,IsoAsp28] Exendin-4(1-39), des Pro36 [Met(O)14 Trp(O2)25, Asp28]Exendin-4(1-39), des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28]Exendin-4(1-39); or des Pro36 [Asp28] Exendin-4(1-39), des Pro36[IsoAsp28] Exendin-4(1-39), des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39), des Pro36 [Trp(O2)25,Asp28] Exendin-4(1-39), des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39), des Pro36[Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39),

wherein the group -Lys6-NH2 may be bound to the C-terminus of theExendin-4 derivative;or an Exendin-4 derivative of the sequence

H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2, des Asp28 Pro36,Pro37, Pro38Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro38 [Asp28]Exendin-4(1-39)-NH2, H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28]Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36 [Trp(O2)25, Asp28]Exendin-4(1-39)-Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25]Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25,Asp28] Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25,Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38[Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36[Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2, des Met(O)14 Asp28 Pro36,Pro37, Pro38 Exendin-4(1-39)-NH2,

H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14,Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38[Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Lys6-des Pro36[Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2, H-des Asp28Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25] Exendin-4(1-39)-NH2,H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2,H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25,Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38[Met(O)14, Trp(O2)25, Asp28] Exendin-4(S1-39)-(Lys)6-NH2,H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2;

or a pharmaceutically acceptable salt or solvate of any one of theafore-mentioned Exedin-4 derivative.

Hormones are for example hypophysis hormones or hypothalamus hormones orregulatory active peptides and their antagonists as listed in RoteListe, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin,Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin),Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin,Buserelin, Nafarelin, Goserelin.

A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid,a heparin, a low molecular weight heparin or an ultra low molecularweight heparin or a derivative thereof, or a sulphated, e.g. apoly-sulphated form of the above-mentioned polysaccharides, and/or apharmaceutically acceptable salt thereof. An example of apharmaceutically acceptable salt of a poly-sulphated low molecularweight heparin is enoxaparin sodium.

Pharmaceutically acceptable salts are for example acid addition saltsand basic salts. Acid addition salts are e.g. HCl or HBr salts. Basicsalts are e.g. salts having a cation selected from alkali or alkaline,e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), whereinR1 to R4 independently of each other mean: hydrogen, an optionallysubstituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenylgroup, an optionally substituted C6-C10-aryl group, or an optionallysubstituted C6-C10-heteroaryl group. Further examples ofpharmaceutically acceptable salts are described in “Remington'sPharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), MarkPublishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia ofPharmaceutical Technology.

Pharmaceutically acceptable solvates are for example hydrates.

The scope of the invention is defined by the content of the claims. Theinvention is not limited to specific embodiments but comprises anycombination of elements of different embodiments. Moreover, theinvention comprises any combination of claims and any combination offeatures disclosed by the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments are described herein with reference to thedrawings, in which:

FIG. 1 illustrates a pen type drug delivery device;

FIG. 2 illustrates a cartridge that may be loaded into a cartridgeholder of the pen type drug delivery device illustrated in FIG. 1;

FIG. 3 illustrates an arrangement of a cartridge holder that includescoding features that help dedicate the cartridge holder to a particulardose setting member;

FIG. 4A shows the interaction of exemplary coding features on acartridge holder with exemplary coding features on a dose settingmember;

FIG. 4B also shows the interaction of exemplary coding features on acartridge holder with exemplary coding features on a dose settingmember;

FIG. 5A shows a coding path associated with an exemplary arrangement ofcoding features;

FIG. 5B shows another coding path associated with an exemplaryarrangement of coding features;

FIG. 5C shows another coding path associated with an exemplaryarrangement of coding features;

FIG. 6A shows an exemplary arrangement of pin features on a cartridgeholder;

FIG. 6B shows another exemplary arrangement of pin features on acartridge holder;

FIG. 6C shows another exemplary arrangement of pin features on acartridge holder;

FIG. 7 shows an exemplary cartridge holder having an ejection feature;

FIG. 8 shows an exemplary cartridge holder having a pin featureextending proximally from the shoulder of the cartridge holder;

FIG. 9 shows an exemplary cartridge holder having a pin featureextending proximally from the proximal end of the cartridge holder;

FIG. 10A shows exemplary cross-sections of the coding features; and

FIG. 10B shows exemplary cross-sections of the coding features from adifferent perspective than shown in FIG. 10A.

DETAILED DESCRIPTION

Referring to FIG. 1, there is shown a drug delivery device 10 in theform of a pen type syringe. This drug delivery device 10 comprises adose setting member 12 which serves as dose setting and deliverymechanism, a cartridge holder 14, and a removable cap 16. A proximal end15 of the cartridge holder 14 and a distal end 13 of the dose settingmember 12 are removably secured together. The pen type syringe maycomprise a re-usable or a disposable pen type syringe. Where the syringecomprises a re-usable device, the cartridge holder 14 and the dosesetting mechanism are removably coupled together. In a disposabledevice, they may be permanently coupled together. When the drug deliverydevice is not in use, the removable cap 16 can be releasably retainedover the cartridge holder 14.

The cartridge holder contains a removable cartridge 20 containing amedicament 25. Referring to FIG. 1, the cartridge holder 14 houses aremovable cartridge 20. FIG. 2 illustrates a perspective view of thecartridge 20 that may be used with the drug delivery device illustratedin FIG. 1.

An inner cartridge cavity 11 defined by the cartridge holder 14 isdimensioned and configured to securely receive and retain the cartridge20. The cartridge 20 includes a generally tubular barrel 22 extendingfrom a distal end 31 to a proximal end 32. The distal end 31 is definedby an inwardly converging shoulder 70.

At the distal end 31, the cartridge 20 includes a smaller diameter neck26, and this neck 26 projects distally from the shoulder 70 of thebarrel 22. Preferably, this smaller diameter neck 26 is provided with alarge diameter annular bead (not shown) and this bead extendscircumferentially thereabout at the extreme distal end of the neck 26. Apierceable seal or septum 21 is securely mounted across the open distalend defined by the neck. The seal 21 may be held in place by a metallicsleeve 24. This sleeve 24 may be crimped around the circumferential beadat the distal end of the neck 26. The medicament is pre-filled into thecartridge 20 and is retained within the cartridge, in part, by thepierceable seal 21, the metallic sleeve 24, and the stopper 28. Thestopper 28 is in sliding fluid-tight engagement with the inner tubularwall of the barrel 22. Forces directed axially in the distal directionupon the stopper 28 during dose administration urges the medication fromthe cartridge 20 though a double ended needle mounted onto the distalend of the cartridge holder 14.

A number of doses of a medicament may be dispensed from the cartridge20. Preferably, the cartridge 20 contains a type of medicament that mustbe administered often, such as once or more times a day. One suchmedicament is insulin. A movable piston which also serves as stopper 28is retained in a first end or proximal end of the cartridge 20.

A portion of the cartridge holder 14 defining the cartridge holdercavity 11, which is formed by the inner cylindrical wall of cartridgeholder 14, is of substantially uniform diameter and is smaller than thecartridge diameter of cartridge 20 represented in FIG. 2 by D₁. Theinterior of the cartridge holder 14 includes an inwardly-extendingannular portion or stop 18 that is dimensioned to prevent the cartridge20 from moving within the cartridge holder 14. In this manner, when thecartridge 20 is loaded into the cavity 11 of the cartridge holder 14 andthe cartridge holder 14 is then connected to the dose setting member 12,the cartridge 20 will be securely held within the cartridge cavity 11.

The dose setting member 12 comprises a dose setter 17 at the proximalend of the dose setting member 12. In one preferred arrangement, thedose setter 17 is rotated to set a dose. To administer this set dose,the user attaches the needle assembly (not shown) comprising a doubleended needle on the distal end of the cartridge holder 14. In thismanner, the needle assembly pierces the seal 21 of the cartridge 20 andis therefore in liquid communication with the medicament. The userpushes on the dose setter 17 to inject the set dose. The same dosesetting and dose administration procedure is followed until themedicament in the cartridge 20 is expended and then a new cartridge mustbe loaded in the device 10. To exchange an empty cartridge 20, the useris called upon to remove the cartridge holder 14 from the dose settingmember 12.

In general, cartridge dedication (e.g., the coding of a particularcartridge holder to a matching dose setting member) may be achieved byarranging coding features on the cartridge holder 14 to align withcoding features on the corresponding dose setting member 12 so as torequire an identifiable connection path (e.g., a distinct sequence ofaxial, helical, and/or rotational movements) and/or prevent mismatchedcartridge holders 14 and dose setting members 12 from being connected.Typically, the coding features align so that rotation in one direction(i.e., clockwise or counter-clockwise) causes the shoulder of thecartridge holder 14 and the distal end 13 of the dose setting member tomove towards each other, or in other words, connects the cartridgeholder 14 and the dose setting member 12. Rotation in the oppositedirection may therefore disconnect the cartridge holder 14 and the dosesetting member 12 (e.g., cause the shoulder of the cartridge holder 14and the distal end 13 of the dose setting member 12 to move away fromeach other).

FIG. 3 illustrates a first arrangement of a cartridge holder 300 thatincludes coding features that help dedicate the cartridge holder 300 toa particular dose setting member 302. The cartridge holder 300 has atubular body having a cylindrical inner surface that defines the cavitydesigned to hold a medicament cartridge. Cartridge holder 300 andconnector portion 309 defines a cylindrical inner wall and a cylindricalouter wall 314. The tubular body extends from the stop (not shown) to ashoulder 306. Shoulder 306 is arranged such that when cartridge holder300 is connected to dose setting member 302, the proximal side ofshoulder 306 sits flush against the distal end 308 of the dose settingmember 302. A connector portion 309 of cartridge holder 300 extends fromthe shoulder 306 to a proximal end 310 of cartridge holder 300.Fastening groove 316 on the connector portion 309 engages fastening pin328 on the inside surface of dose setting member 302 to form thefastening means to connect the cartridge assembly to the dose settingmember 302. The fastening pin 328 may move along to the groove 316 toits end portion 317. Likewise, it should be understood that embodimentswith a single groove feature or more than two groove features, as wellas embodiments with differently shaped groove features, are alsopossible. Alternatively, the fastening groove 316 could be located onthe dose setting member 302 and the fastening pin 328 could be locatedon the cartridge assembly. Indeed, generally, any fastener feature knownto art of injection devices may be used.

Also included on the connector portion 309 is a coding feature,illustrated as a stop 318. This coding feature has a complimentarycoding feature on dose setting member 302, shown as a counter stop 330.More generally, a coding feature may be any indentation or protrusion,in any direction, of any size, and/or of any shape, from a cartridgeholder 300 or dose setting member 302. As illustrated, the codingfeature 318 is a square-shaped protrusion, however, such stop featuresmay vary in size, shape, and location. For instance, a coding featuremay be defined by helical, rotational, and/or axial surfaces of varyingnumber and extent. Preferably, these coding features on cartridge holder300 and dose setting member 302 are coded such that, if the particularcartridge holder is not intended for the particular dose setting member,the coding features will prevent proper connection, or otherwiseindicate that cartridge holder 300 and dose setting member 302 aremismatched.

FIGS. 4 to 6 show in greater detail the interaction between codingfeatures on the cartridge holder 300 and dose setting member 302,illustrated as projections around the circumference. Shaded features areon one part and plain features are on the other, for example if shadedfeatures are on the dose setting member 302 then the plain featureswould be on the cartridge holder 300. In particular, FIG. 4A shows theinteraction of coding features 316 and 318, and fastener 328, 328 a,330, and 330 a. Note that a second set of coding features 316 a and 318a, which may be identical to coding features 316 and 318 are alsoillustrated. The various coding features on the dose setting member 302may work together to help dedicate a particular cartridge holder 300 toparticular dose setting member 302. For example, FIGS. 4A and 4B showhow the coding features of cartridge holder 300 preferably align withthe coding features of the dose setting member 302 when properlyconnected. In particular, when properly connected stop feature 318securely engages counter stop 330.

More specifically, fastening groove feature 316 and fastening pinfeature 328 are configured such that cartridge holder 300 and dosesetting member 302 may be connected by guiding the dose setting memberaxially, helically, and then rotationally, until axial surface 348 ofthe cartridge holder 300 contacts the axial surface 358 of dose settingmember 302. A proximal surface 346 of the cartridge holder 300 contactsa distal surface 356 of the dose setting member 302. This arrangementthus helps code cartridge holder 300 to dose setting member 302. And, iffastening pin feature 328 is not coded to match fastening groove feature316, then the pin feature will either be blocked (e.g., the pin featurehas an axial extent greater than the axial extent of the groove featurebetween the proximal and distal helical surfaces 340, 342), or will notfit securely (e.g., the pin feature has an axial extent less than theaxial extent of the groove feature between the proximal and distalhelical surfaces 340, 342). Although the main coding is between 330 and318, the coding could also be fastening pin to groove. Additionally, ifcoding feature 330 is not coded to match coding feature 318, then codingfeature 318 may contact coding feature 330 too early and hence preventcomplete assembly of fastening pin 328 into fastening groove feature342.

FIG. 4B shows an alternative embodiment also comprising fastening groovefeatures 416, 416 a and fastening pin features 428, 428 a where codingfeatures 418, 418 a are counter stops located on the dose setting memberand coded to engage stops 430, 430 a by making contact along at leastthe axial face. However, contact between the stop features may be in anydirection such as axial, helical or circumferential, although thedirection of contact would preferably be normal to the direction oftravel at the time of contact. For example in other embodiments, such asthose shown in FIGS. 5A, 5B and 5C, coding features having alongitudinal portion 510 a-c and radial portions 512 a-c, block bothrotational and axial movement.

In preferred embodiments the fastening means would follow the same pathfor all drugs in the coding system, but the coded blocking or stopfeatures would be offset from the fastening means by a different amountfor each drug. As such, coding may be accomplished, at least in part, byvarying the axial, radial, and/or circumferential position of the codingfeatures so as to vary the axial, radial, and/or circumferentialposition of the coding path. The pin and groove of the fasteningassembly are not shown, but assembly of the pin into the groove guidesthe coding features along the coding paths illustrated as dotted lines.The shape of the coding path is therefore defined by the fasteningaction, for example fastening pin 328 following fastening groove feature316, but its position passes through the coding features. For instance,FIGS. 5A-C show three different possible coding paths 502, 504, and 506,which may be achieved using various coding-feature configurations. Assuch, each coding path may be used to dedicate a cartridge holder for aparticular medicament to its corresponding dose setting member.

If there is only one coded stop feature, then a cartridge holder wherethe travel of the stop feature is blocked early in the fastening actionwill fit into a device where the travel is blocked later. The sameproblem exists with more than one stop feature, if the all stop featuresfor a given drug are offset by the same distance relative to anotherdrug. FIGS. 5A-C show a coding system that depends on more than oneblocking or stopping face, so that all drugs can be prevented from beingfitted into an incorrect device. FIG. 5B shows both features in theircentral position. For the other drugs, i.e. FIGS. 5A and 5C, one codingfeature is moved towards the start of the fastening travel, and onecoding feature is moved later in the fastening travel. In this way, noneof the cartridge assemblies in the system can be fitted to incorrectdevices.

FIGS. 6A-C also illustrate exemplary cartridge holders having multipleblocking or stopping faces, which match corresponding coding features onthe corresponding dose setting members. In particular, when a user movescoding features 610 a and 620 a through coding path 602, coding features610 a and 620 a of the dose setting member engage features 612 a and 622a of the cartridge holder, indicating to the user that the properconnection has been achieved. Similarly, features 610 b and 620 b may bemoved through coding path 604 to engage features 612 b and 622 b, andfeatures 610 c and 620 c may be moved through coding path 606 to engagefeatures 612 c and 622 c.

Since the pairs of features 610 a/620 a, 610 b/620 b, and 610 c/620 c(and their corresponding or complimentary features 612 a/622 a, 612b/622 b, and 612 c/622 c on the dose setting members), are each orienteddifferently with respect to each other, one pair may block travelearlier or later in the connection process than another pair, thushelping dedicate a particular cartridge to its corresponding dosesetting member. FIG. 6A shows both features in their central position.For the other drugs, i.e., FIGS. 6B and 6C, one coding feature is movedtowards the start of the fastening travel, and one coding feature ismoved later in the fastening travel. In this way, none of the cartridgeassemblies in the system can be fitted to incorrect devices.

In another aspect, a cartridge holder may include an ejection feature,which ejects the cartridge holder if it is inserted into the incorrectdose setting member. FIG. 7 shows an exemplary cartridge holder 700having an ejection feature. In particular, the fastening groove featurein cartridge holder 700 may include an ejection channel 710. As shown,the coding features are arranged to provide coded stop features 718 and730 that are arranged to engage and block rotational movement whenproperly connected. These stops prevent rotational movement of fasteningpin feature 728 of the dose setting member 702 into the ejection channel710. However, if the cartridge holder 700 is inserted into a dosesetting member 702 that does not match, i.e. stops 718 and 730 do notengage, then the fastening pin feature 728 on the dose setting member702 may over-rotate into the ejection channel 710. Once in this channel,the pin 728 will be loose and it will be obvious to the user that thefastening operation has failed. As an added safety measure, thecartridge assembly 700 or the dose setting member 702 can be designedsuch that further rotation in the fastening direction will force the pinacross or into a one-way element. In particular, once in this one-wayelement the fastening pin contacts a ramp, and the holder (or device)flexes to allow the pin to pass into the start of one of the fasteninggrooves. The side of the one-way element adjacent to the groove has asteeper angle, so the pin cannot return, or enter the ejection channelduring normal fastening. Additionally, a spring mechanism can be addedto the device to force the cartridge holder in a distal direction, thusejecting it from the dose setting member helping to ensure that only acorrect cartridge holder is connected.

FIG. 8 shows an alternative embodiment, which includes a stop feature818 extending proximally from the shoulder 809 of the cartridge holder800. Stop feature 818 is coded to match a coded groove feature 830 ondose setting member 802. Specifically, to correctly connect cartridgeholder 800 to dose setting member 802, stop feature 818 is movedhelically along helical surface 820 until the proximal edge of stopfeature 818 contacts the surface 822 of groove feature 830. Thecartridge holder 800 is then rotated until the stop feature contacts theaxial surface or face of counter stop 824 of groove feature 830, thusstopping rotational movement. This arrangement may be more compact thanother embodiments, and the shoulder may help protect the coding features818, 830 from damage.

FIG. 9 shows another alternative embodiment, which includes a stopfeature 918 extending proximally from the proximal end 910 of thecartridge holder 900. Unlike the other stop features discussed herein,this coding feature 918 does not protrude radially from the outer wallof the cartridge holder, but instead protrudes proximally from theproximal end 910 of cartridge holder. The coding feature correspondingto stop feature 918 on dose setting mechanism 902 is coded groovefeature 928 with counter stop face 931. Groove feature 928 is an axialindentation on a circular ridge 930 of dose setting mechanism 902. Thecircular ridge 930 is preferably arranged such that, when properlyconnected, the ridge contacts (or very nearly contacts) the proximal end910 of cartridge holder 900. As such, if the stop feature 918 contactsthe ridge (and is not inserted into groove feature 930), a gap willremain between the distal end 914 of dose setting mechanism 902 andshoulder 909 of cartridge holder 900. This gap may therefore serve toindicate an incorrect connection to the user.

In a further aspect, any coding feature of the cartridge holder and/ordose setting member may vary in size and shape in one or more planes(e.g., transverse, longitudinal, and/or radial plane). For example, FIG.10A shows an exemplary collection of stop features having cross-sections102-112 through a transverse plane, each of which might be used for adifferent medicament. The cross-section for each drug is larger in onearea and smaller in another than for all of the other drugs, which canbe seen by overlaying all of the cross-sections in sketch 100. In thisway, if the wrong cartridge holder is inserted into the device, the stopwill block travel before the holder is fully assembled. FIG. 10B showsanother collection of possible coding features having cross-sections1102-1112, but through the longitudinal plane (i.e. the plane normalizedto the curvature of coding feature). The cross-section for each drug islarger in one area and smaller in another than for all of the otherdrugs, which can be seen by overlaying all of the cross-sections insketch 1100. A given coding feature might be coded in a transverse planeas in 10A, or it might be coded in a longitudinal plane as in 10B, orboth.

Each stop may vary in shape and size. For instance, as shown in FIG.10A, the stops may vary in radial extent and/or circumferential extent(e.g., stops 102-106 are both radially narrower and circumferentiallylonger than stops 108-112). The coding features may also vary in axialextent and the edges may vary angularly. For example, as shown, bothedges of stop 102 and both edges of stop 108 are normal to thecircumference of the coding feature (and thus to the circumference ofthe outer cylindrical wall of the cartridge holder), while stops 104,106, 110, and 112 each include one edge that is normal to thecircumference, and one edge that is angled relative to thecircumference.

In another aspect, coding features may include electro-mechanicalverification features; e.g. electrical or optical sensors,microswitches, optical switches, magnetic switches, etc. For example,when a cartridge holder is connected to the correct dose setting member,a switch on an edge of a coding feature (on the cartridge holder and/orthe dose setting member) may be triggered. As another example, a sensoron the coding feature of a cartridge holder may be configured to detecta matching sensor on the coding feature of the matching dose settingmember. The cartridge-holder sensor may be located so that it onlyaligns with (and thus detects) the matching sensor on the dose settingmember when properly connected. As such, a programmable drug deliverydevice may be disabled until the switch is triggered or sensors arebrought into alignment, helping prevent incorrect administration ofmedicament.

Applicants' cartridge holders and dose setting members help provide alarge number of different coding configurations. Consequently, withproposed coding features, a large number of medicaments can bedistinguished from one another. In addition, with Applicants' proposedcoding features, if a user attempts to load an incorrect reservoir intoa cartridge holder designed for a different cartridge, the user will bealerted at an early stage of the assembly process.

Exemplary embodiments have been described. It should be understood that,in general, the functionality and structural aspects described hereinwith reference to pin or groove features on a cartridge holder may applyequally with respect to pin or groove features on a dose setting member.Those skilled in the art will understand, however, that changes andmodifications may be made to these arrangements without departing fromthe true scope and spirit of the present invention, which is define bythe claims.

1. A cartridge assembly configured for connection to a dose setting anddelivery mechanism, the cartridge assembly comprising: a cylindricalbody for holding a medicament reservoir, where the cylindrical body hasa proximal end portion having an outer surface and an inner surface; afastener on the outer surface of the proximal end portion, the fastenerconfigured to attach the cartridge assembly to the dose setting anddelivery mechanism through a combination of axial and rotationalmovements; and a fastening pin projecting radially outward from theproximal end portion configured to engage a cooperating fastening pinlocated on a distal inner surface of the dose setting and deliverymechanism, where the fastening pin is separate from the fastener and isconfigured to engage the cooperating fastening pin thereby allowing thecartridge assembly to operably connect to the dose setting and deliverymechanism.
 2. The cartridge assembly of claim 1 where the fastening pinis located distally from the fastener.
 3. The cartridge assembly ofclaim 1 where the fastening pin engages the cooperating fastening pinduring the rotational movement.
 4. The cartridge assembly of claim 1where the outer surface on the proximal end of the cylindrical body ispositioned between a shoulder and a proximal axial end and the fastenerand fastening pin are located on the outer surface and where thefastening pin abuts a proximal facing surface of the shoulder.
 5. Thecartridge assembly of claim 1 where the fastener is selected from thegroup consisting of threads, pins and grooves, pins and ridges, bayonet,snap-fit, and detents.
 6. The cartridge assembly of claim 1 where thefastener is a bayonet fitting.
 7. The cartridge assembly of claim 1further characterized in that the fastening pin and the cooperatingfastening pin only engage if the cartridge holder and dose setting anddelivery mechanism are dedicated to each other.
 8. A drug deliverydevice comprising, a dose setting member having a distal end with aninner surface, and a cartridge assembly comprising, a cylindrical bodyfor holding a medicament reservoir, where the cylindrical body has aproximal end portion having an outer surface; a fastener on the outersurface of the proximal end portion, the fastener being configured toattach the cartridge assembly to the dose setting member through abayonet connector; and a fastening pin projecting radially outward fromthe proximal end portion that is configured to engage a cooperatingfastening pin located on the inner surface of the dose setting member,wherein the fastening pin and cooperating fastening pin are separatefrom the bayonet connector and where the fastening pin and thecooperating fastening pin engage thereby allowing the cartridge assemblyto operably connect to the dose setting and delivery mechanism.
 9. Thedrug delivery device of fastening pin and the cooperating fastening pinonly engage if the cartridge holder and dose setting member arededicated to each other.
 10. A cartridge assembly configured to beconnected to a dose setting and delivery mechanism, the cartridgeassembly comprising: a cylindrical body for holding a medicamentreservoir, where the cylindrical body has a proximal end portion havingan outer surface and an inner surface; a fastener on either the outersurface or the inner surface of the proximal end portion, the fastenerbeing configured to attach the cartridge assembly to the dose settingand delivery mechanism; and at least one coding feature that is separatefrom the fastener, the coding feature being coded to engage acorresponding coding feature on the dose setting and delivery mechanism,thereby allowing the cartridge assembly to operably connect to the dosesetting and delivery mechanism, where the coding feature is formed asstop feature and where the corresponding coding feature is formed ascounter stop feature, the stop feature and the counter stop featurebeing suitable to make contact and allowing the cartridge assembly tooperably connect to the dose setting and delivery mechanism.